Cleared Special

LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR (K033899) - FDA 510(k) Clearance

Class I Chemistry device.

K033899 · Lifestream Technologies, Inc. · Chemistry device
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May 2004
Decision
155d
Days
Class 1
Risk

K033899 is an FDA 510(k) clearance for the LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL M.... Classified as Test, Cholesterol, Total, Over The Counter (product code NFX), Class I - General Controls.

Submitted by Lifestream Technologies, Inc. (Post Falls, US). The FDA issued a Cleared decision on May 20, 2004 after a review of 155 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Lifestream Technologies, Inc. devices

Submission Details

510(k) Number K033899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2003
Decision Date May 20, 2004
Days to Decision 155 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 88d · This submission: 155d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NFX Test, Cholesterol, Total, Over The Counter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.